MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-29 for PERSONA STEMMED TIBIA N/A 42532007102 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[177538538]
(b)(4). Medical product: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400713 lot # 63029895, persona all poly patella catalog # 42540200035 lot # 63326893, 3. 5mm hex head screw x38mm catalog # 20800000018 lot # unknown. The complainant has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Event was initially reported on 0001822565-2019-04978. Multiple mdr reports were filled for this event: 3007963827-2020-00040, 0001822565-2019-04979, 0001822565-2019-05075. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[177538539]
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was experienced a blood clot from the surgery. Attempt for further information has been made, but no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2020-00039 |
| MDR Report Key | 9643265 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2016-04-21 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Street | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE |
| Manufacturer City | SHANNON, COUNTY CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA STEMMED TIBIA |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2020-01-29 |
| Model Number | N/A |
| Catalog Number | 42532007102 |
| Lot Number | 63315961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Address | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |